Repris Bladder Injection System— 510(k) K180214

Substantially Equivalent

Uro-1, Inc.

FDA 510(k) clearance K180214 for Repris Bladder Injection System, Substantially Equivalent on 2018-05-03. Applicant: Uro-1, Inc..

Clearance details

Applicant: Uro-1, Inc.
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2018-01-25
Decision date: 2018-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston Salem, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.